N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis (NACPSY)
This study is currently recruiting participants.
Verified May 2011 by Beth Israel Deaconess Medical Center
Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
Center de Neurosciences Psychiatrique, Lausanne, Switzerland
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01354132
First received: May 13, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
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Purpose
The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur during the pre-illness phase and around the transition to psychosis. Therefore, studying new treatments that could target changes occurring during this period is of critical importance.
Aims:
Does add-on NAC treatment in early psychosis influence:
- positive and negative symptoms
- extrapyramidal side-effects of other medication
- plasma concentration of glutathione
- Mismatch Negativity, a physiological marker
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenic Psychoses |
Drug: n-acetylcysteine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Oral N-Acetyl-Cysteine (NAC) in the Early Phase of Schizophrenia Spectrum Psychosis: Randomized, Parallel, Double- Blind, Placebo Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Beth Israel Deaconess Medical Center:
Primary Outcome Measures:
- Improvement of negative symptoms on the PANSS [ Time Frame: within 6 months of NAC treatment ] [ Designated as safety issue: No ]Positive and Negative Syndrome Scale
Secondary Outcome Measures:
- Improved positive and general symptoms (PANSS) and functional level (GAF & SOFAS) [ Time Frame: within 6 months of NAC treatment ] [ Designated as safety issue: No ]Positive and Negative Syndrome Scale Global Assessment of Functioning Social and Occupational Functioning Assessment Scale
- Improved cognition and working memory (MATRICS) [ Time Frame: at 24 weeks of NAC treatment ] [ Designated as safety issue: No ]The MATRICS is neurocognitive battery designed to assess cognition in psychopharmacology studies
- Improved EEG/Evoked potentials (Mismatch Negativity) [ Time Frame: at 24 weeks of NAC treatment ] [ Designated as safety issue: No ]Mismatch Negativity, a component of auditory evoked potentials
- Improved plasma glutathione [ Time Frame: within 24 weeks of NAC treatment ] [ Designated as safety issue: No ]Plasma levels of glutathione, plasma amino acids and genetic analysis of enzymes involved in glutathione metabolism
| Estimated Enrollment: | 33 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: n-acetyl-cysteine |
Drug: n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
Other Name: PharmaNAC
|
| Placebo Comparator: Placebo |
Drug: n-acetylcysteine
900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
Other Name: PharmaNAC
|
Detailed Description:
The study proposes that a glutathione deficit leading to an abnormal response to oxidative stress is a vulnerability factor, combined with other brain specific factors, in brain functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is hypothesized to cross the blood-brain barrier and increase glutathione in the brain.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Capacity to provide informed consent
- DSM IV TR diagnosis of schizophrenia, schizophreniform, schizoaffective
- Psychiatric and medical stability
- Prescribing clinician's premission to participate, assurance of medical stability
- Having met threshold criteria for psychosis on CAARMS (Comprehensive Assessment of at Risk Mental States Scale) Psychosis subscale
- Up to 12 months of antipsychotic treatment
Exclusion Criteria:
- Severe medical comorbidities
- Previous cerebral trauma
- Substance induced psychosis or organic psychosis
- Mental retardation
- NAC allergy
- Pregnancy, females and males planning pregnancy
- Treatment with antioxidants
- Insufficient command of English
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354132
Contacts
| Contact: Corin Pilo, MA | 617-998-5016 | cpilo@bidmc.harvard.edu |
| Contact: Ann Cousins, PhD, APRN | 617-626-9381 | acousins@bidmc.harvard.edu |
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Sub-Investigator: T. U. Wilson Woo, MD, PhD | |
| Massachusetts Mental Health Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Sub-Investigator: T. U. Wilson Woo, MD, PhD | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Center de Neurosciences Psychiatrique, Lausanne, Switzerland
Investigators
| Study Director: | Ann Cousins, PhD, APRN | Beth Israel Deaconess Medical Center |
| Study Chair: | T. U. Wilson Woo, MD, PhD | Harvard Medical School |
More Information
Publications:
| Responsible Party: | Larry J. Seidman, Ph.D., Beth Israel Deaconess Medical Center, Commonwealth Research Center |
| ClinicalTrials.gov Identifier: | NCT01354132 History of Changes |
| Other Study ID Numbers: | BIDMC 42, 107865 |
| Study First Received: | May 13, 2011 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Deaconess Medical Center:
|
schizophrenia schizoaffective schizophreniform early schizophrenia spectrum psychosis |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 16, 2013